Expandable body device and method of use

Abstract

Disclosed herein are medical devices comprising a single-lobed, thin-walled, expandable body (“ballstent” or “blockstent”) and a flexible, elongated delivery device (“delivery catheter”) and systems and methods of use for treating saccular vascular aneurysms and methods of use for occluding segments of blood vessels and other biological conduits. Expandable bodies comprising gold, platinum, or silver that can be compressed, positioned in the lumen of an aneurysm or blood vessel, and expanded to conform to the shape of the aneurysm or segment of blood vessel or biological conduit are disclosed. The external surface of the expandable bodies can be configured to promote local thrombosis and to promote the growth of tissue into and around the wall in order to reduce migration of the expandable body and to occlude and seal the aneurysm or biological conduit. The wall of the expandable bodies can also be configured to release drugs or pharmacologically active molecules, such as those that promote thrombosis, cell proliferation, extracellular matrix deposition, or tissue ingrowth.

What is claimed is: 
     
         1 . A medical device, comprising:
 a hollow structure, initially in a pleated and folded configuration, comprising:
 a proximal neck and a distal neck; 
 a wall with an interior surface that defines a central void, wherein the wall of the hollow structure comprises a polymer layer; 
 a proximal opening, defined by the proximal neck that allows for the passage of fluid from a first lumen into the central void; and a distal opening, defined by the distal neck, that allows for the passage of a guidewire through the wall of the hollow structure; wherein: 
 the passage of fluid into the central void of the pleated and folded hollow structure results in expansion of the pleated and folded hollow structure; 
   at least one metal coil or wire; and wherein;   the hollow structure, when expanded, assumes a shape wherein the body of the expanded hollow structure is generally round or cylindrical;   the hollow structure configured to receive the at least one metal coil or wire; into the central void of the hollow structure after expansion of the hollow structure; and   the expanded hollow structure configured to detach from a catheter, and   wherein the distal neck of the hollow structure is detachably engaged to a second cylindrical member.   
     
     
         2 . The medical device of  claim 1 , wherein the wall of the hollow structure comprises an interior layer comprising a polymer layer and an exterior layer comprising a metal layer. 
     
     
         3 . The medical device of  claim 2 , wherein the exterior metal layer is a continuous layer. 
     
     
         4 . The medical device of  claim 2 , wherein the exterior metal layer is a discontinuous layer. 
     
     
         5 . The medical device of  claim 1 , wherein the expanded hollow structure comprises a single lobe. 
     
     
         6 . The medical device of  claim 1 , wherein, when expanded, the wall of the proximal neck and the distal neck of the hollow structure is thicker than the wall of the body of the hollow structure. 
     
     
         7 . The medical device of  claim 1 , wherein the proximal neck of the hollow structure configured to fit around a distal end of the catheter. 
     
     
         8 . The medical device of  claim 1 , wherein the hollow structure is formed into pleats, and the pleats are folded or compressed against a portion of the catheter. 
     
     
         9 . The medical device of  claim 1 , wherein the pleated and folded hollow structure can be expanded by injection of a fluid into the central void of the hollow structure from a pressurized fluid source. 
     
     
         10 . The medical device of  claim 1 , wherein the hollow structure is attached or engaged to the catheter by a joining or uniting of components. 
     
     
         11 . The medical device of  claim 10 , wherein one component is fixed to the catheter and a second component is fixed to the proximal neck of the hollow structure. 
     
     
         12 . The medical device of  claim 10 , wherein, after expansion of the hollow structure, the components can be detached, disengaged or separated, resulting in separation of the expanded hollow structure and the catheter. 
     
     
         13 . The medical device of  claim 1 , wherein the hollow structure is attached or engaged to the catheter by a fitting of mechanical parts. 
     
     
         14 . The medical device of  claim 1 , wherein the hollow structure is attached or engaged to the catheter by a physical coupling of mated parts, wherein, after expansion of the hollow structure, the mated parts can be detached, disengaged, or separated, resulting in separation of the expanded hollow structure and the catheter. 
     
     
         15 . The medical device of  claim 1 , wherein the hollow structure and the catheter are configured such that the expanded hollow structure and the catheter can be pulled apart. 
     
     
         16 . The medical device of  claim 1 , wherein the hollow structure and the catheter are configured such that the expanded hollow structure and the catheter can be pulled apart by withdrawing the catheter while the expanded hollow structure is held in place. 
     
     
         17 . The medical device of  claim 1 , comprising a component configured to cause detachment, disengagement, or separation of the catheter and the expanded hollow structure. 
     
     
         18 . The medical device of  claim 1 , configured such that the catheter and the expanded hollow structure can be detached, disengaged, or separated after actuation of a component of the medical device.